Premium UNIFY PP Sutures

GUDID 10814639021957

Premium Polypropylene, Sm 5-0, 13mm 3/8 circle Rev Cut, 18"

APPLIED DENTAL, INC.

Polyolefin suture, monofilament
Primary Device ID10814639021957
NIH Device Record Key0360f38b-dea8-44a7-b755-d9f48e5f9eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY PP Sutures
Version Model NumberPSP-518R13
Company DUNS017524666
Company NameAPPLIED DENTAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com
Phone1-888-841-8481
Emailinfo.usa@ad-surgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639021950 [Primary]
GS110814639021957 [Package]
Contains: 00814639021950
Package: box [12 Units]
In Commercial Distribution
GS120814639021954 [Package]
Package: case [100 Units]
In Commercial Distribution

FDA Product Code

GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2015-08-21

On-Brand Devices [Premium UNIFY PP Sutures]

20814639022814Premium Polypropylene, Med 5-0, 16mm 3/8 circle Rev Cut, 18"
20814639022807Premium Polypropylene, Med 4-0, 16mm 3/8 circle Rev Cut, 18"
20814639022432Premium Polypropylene, Sm 4-0, 13mm 3/8 circle Rev Cut, 18"
20814639022425Premium Polypropylene, Med 4-0, 19mm 3/8 circle Rev Cut, 18"
20814639022418Premium Polypropylene, Med 5-0, 19mm 3/8 circle Rev Cut, 18"
10814639021957Premium Polypropylene, Sm 5-0, 13mm 3/8 circle Rev Cut, 18"
10814639024798Premium Polypropylene, Med 3-0, 19mm 3/8 circle Rev Cut, 18"
10814639023746Premium Polypropylene, 3-0, 24mm 3/8 circle Rev Cut, 27"
10814639023739Premium Polypropylene, 4-0, 24mm 3/8 circle Rev Cut, 27"

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.